Risk Communication clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT04058847 Active, not recruiting - Clinical trials for Cardiovascular Risk Factor

Danish Evaluation of Your Heart Forecast.

DANY

Start date: March 27, 2019
Phase: N/A
Study type: Interventional

Under 50% of patients diagnosed with hypertension and treated in general practice, have reached a blood pressure within the recommended levels of the national guideline. Compliance is the main problem for these patients, but effective tools for increasing patient compliance are missing. The objective is to evaluate the risk-assessment and risk-communication tool: "Your Heart Forecast", to see if it can improve patient compliance, health literacy and empowerment. Patients will be followed in a cluster-randomised controlled trial in the setting of general practice, using surveys at inclusion and after 6 and 12 months. Besides surveys, the participants' blood pressure will be measured as a hard outcome and data will be drawn from various patient databases. After 6 months, qualitative interviews will be conducted, with a subgroup of patients from the intervention group. It is expected to find whether the use of Your Heart Forecast can lower patients' blood pressure and/or increase their compliance, health literacy and empowerment. The aim is to show if an increase in general health literacy and patient empowerment, as measured by Patient Activation Measure(PAM13) can be seen. The investigators hope to reveal whether this software can improve patient compliance and thereby be a reasonable tool to implement in the national blood pressure control program. In further studies, it should be shown if the cost of using this program is far less than expenses for hospitalisation due to complications and comorbidity to hypertension.